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Severe weather and biological products

CBER offers information on how to handle temperature-sensitive biologics in power outages or floods.

Spring and summer can usher in severe weather, including flooding and power outages. Such conditions can jeopardize the efficacy of expensive and sensitive biologics.

To address this issue, FDA’s Center for Biologics Evaluation and Research (CBER) provides information concerning the storage and use of temperature-sensitive biological products that have been involved in a temporary electrical power failure or flood conditions.

The following details come from FDA’s website on the subject:

While people should not be put at risk by using a product that may be unsafe due to the conditions under which it was stored, shortages should not be created by discarding product simply because of power failures that may not adversely affect the product. Vials of biological products in contact with flood waters should be discarded given the possibility of contamination and the likelihood of significant exposure to temperatures outside of those recommended for cold chain storage.

Most biological products require specific storage conditions, as indicated in the product labeling, to maintain their safety, purity, and potency. These products include bacterial and viral vaccines, allergenic extracts, plasma derivatives, and other products requiring refrigeration or frozen storage, as well as products that can be stored at controlled room temperature (i.e., not exceptionally cold or hot).

When there is an electrical power failure, whether due to accident, equipment failure, or disruption in the electrical power grid, the temperature control systems for product storage may not function.

Power failures are not only a concern regarding storage in a facility, as failure of the refrigeration or freezer unit on a carrier (e.g., truck) while the products are in transit may also occur. The information below may assist interested persons in determining what to do with their biological products in the event of a power failure.

During normal business hours, questions may be directed to 1-800-835-4709. After business hours parties may call the FDA emergency operations line at 301-796-8240. These questions will be forwarded to the appropriate Center or office for advice.

Vaccines requiring refrigeration or frozen storage

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INTRODUCING! The Latest Trends for Life Sciences at PACK EXPO Southeast